CompletedNCT04922502Updated Mar 4, 2025Results posted

Parent-based Treatment for Youth With Anxiety and Obsessive-compulsive Disorder

An interventional study of Standard SPACE and Bibliotherapy, low therapist contact SPACE in Obsessive-Compulsive Disorder in Children, Social Anxiety Disorder of Childhood and Obsessive-Compulsive Disorder in Adolescence, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 7 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-04.

Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 68
Allocation: Randomized
Ages: 7 Years to 17 Years
Sex: All

Study summary

Anxiety and obsessive-compulsive disorders are the most common mental health disorders in childhood and adolescence. A parenting intervention for youth with anxiety, called Supportive Parenting of Anxious Childhood Emotions ("SPACE"), has been recently developed to help target anxiety in children. In this intervention, therapists meet individually with parents to help them reduce anxiety behaviors in their children and support adaptive behaviors in their children. The purpose for the proposed study is to demonstrate the treatment efficacy of SPACE compared to a low-contact, therapist-supported bibliotherapy version of this intervention.

Read the detailed description

Anxiety and obsessive-compulsive disorders are the most common mental health disorders in childhood and adolescence. Parental accommodation of their children's avoidance, escape, safety behaviors are a set of parenting behaviors that have been most strongly associated with child anxiety and obsessive-compulsive disorder. Developing and testing parent-led interventions that target accommodation and parenting styles associated with anxiety has the potential to improve treatment outcomes and reach families who may not otherwise access care (for example, for youth who refuse to attend therapy). A parenting intervention for youth with anxiety has been recently developed to address these goals called Supportive Parenting of Anxious Childhood Emotions ("SPACE"). In this intervention, therapists meet individually with parents to help them reduce accommodation and support adaptive behaviors in their children. SPACE was recently shown to be non-inferior to individual cognitive-behavioral therapy with 88% of youth being classified as responders to SPACE. The purpose for the proposed study is to demonstrate the treatment efficacy of SPACE compared to a low-contact, therapist-supported bibliotherapy version of this intervention, providing efficacy evidence for SPACE as delivered by an independent investigatory group.

Conditions studied

Obsessive-Compulsive Disorder in Children
Social Anxiety Disorder of Childhood
Obsessive-Compulsive Disorder in Adolescence
Separation Anxiety
Generalized Anxiety Disorder
Panic Disorder
Panic Attacks
Panic With Agoraphobia

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Keywords

obsessive-compulsive disorder
children
cognitive behavioral therapy
anxiety

In context

Anxiety, Separation

59 studies on the registry are indexed under Anxiety, Separation; 5 are open to participants now.

This study's enrollment of 68 is close to the median of 68 across 53 interventional studies indexed under Anxiety, Separation.

Browse Anxiety, Separation studies →

Lead sponsor

Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.

Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 7 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

The child is between the ages of 7 to 17 at enrollment
The child has symptoms of anxiety and/or OCD, as indicated by a score of 12 or higher on the Pediatric Anxiety Rating Scale (PARS).
The child is appropriate for anxiety-focused treatment (e.g., anxiety is the primary problem as diagnosed using the Anxiety Disorders Interview Schedule (ADIS), and if secondary psychopathology is present it will not interfere with treatment).
One parent/guardian is able and willing to participate in assessment and treatment (e.g., has sufficient English fluency, the decisional capacity to participate, and can commit to treatment duration).
The participating parent/guardian lives with their child at least 50% of the time.
Both parent and child are able to read and understand English.
The child is able to communicate verbally.
Participants must reside in Texas and parents must be in the state of Texas when taking calls.

Exclusion criteria

Exclusion Criteria:

the child has a diagnosis of child lifetime bipolar disorder, drug of alcohol abuse, intellectual or developmental disability, psychotic disorder, or conduct disorder.
the child has severe, current suicidal/homicidal ideation and/or self-injury requiring medical intervention (referrals will be made for appropriate clinical intervention).
the child is receiving concurrent evidence-based psychotherapy for anxiety, involving exposure therapy in at least 50% of sessions.
the child has initiated or changed dosage of psychotropic medications within 4 weeks before study enrollment OR stimulant or benzodiazepine medications within 2 weeks before study enrollment. If appropriate, the child may be enrolled in the study once medication dosage has stabilized (i.e., 4 weeks for psychotropic medication or 2 weeks for stimulant/benzodiazepine medication).

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant: Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 68 participants (actual)

Study arms

Active comparator
Standard SPACE
12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.
Behavioral: Standard SPACE
Active comparator
Bibliotherapy, low therapist contact SPACE
4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD".
Behavioral: Bibliotherapy, low therapist contact SPACE

Interventions

BehavioralStandard SPACE
12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.
BehavioralBibliotherapy, low therapist contact SPACE
4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD".

What researchers measure

Primary outcomes

Pediatric Anxiety Rating Scale
Clinician-rated child anxiety severity throughout the past week. Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 35.
Time frame: Baseline (before treatment), post-treatment assessment (on average 12 weeks), one month follow up; Baseline scores reported.

Secondary outcomes

Anxiety Disorders Interview Schedule (ADIS-IV) With Clinical Severity Ratings
Clinician-rated diagnostic interview that includes current anxiety disorders, depression, obsessive-compulsive disorder, and related disorders. Each diagnostic category is coded as present or absent based on symptom criteria and clinical severity ratings (CSRs), which indicate the level of clinical interference. CSRs are scored on a 0-8 scale (0 = not at all; 8 = very, very much). CSRs of 4 or above indicate the clinical levels.
Time frame: Up to 24 weeks
Clinical Global Impression-Severity
Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).
Time frame: Baseline (before treatment), post-treatment assessment (on average 12 weeks), one month follow up; Baseline scores reported.

Results

Posted Jan 15, 2025

Participant flow

Participant flow — Overall Study
Milestone	Standard SPACE	Bibliotherapy, Low Therapist Contact SPACE
Started	66	70
Completed	60	62
Not completed	6	8

Outcome measures

PrimaryPediatric Anxiety Rating Scale

Clinician-rated child anxiety severity throughout the past week. Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 35.

Time frame:: Baseline (before treatment), post-treatment assessment (on average 12 weeks), one month follow up; Baseline scores reported.
Reported as:: Mean · score on a scale

Pediatric Anxiety Rating Scale
score on a scale	Standard SPACE	Bibliotherapy, Low Therapist Contact SPACE
Pediatric Anxiety Rating Scale	10.86 ± 4.80	10.96 ± 6.08

SecondaryAnxiety Disorders Interview Schedule (ADIS-IV) With Clinical Severity Ratings

Clinician-rated diagnostic interview that includes current anxiety disorders, depression, obsessive-compulsive disorder, and related disorders. Each diagnostic category is coded as present or absent based on symptom criteria and clinical severity ratings (CSRs), which indicate the level of clinical interference. CSRs are scored on a 0-8 scale (0 = not at all; 8 = very, very much). CSRs of 4 or above indicate the clinical levels.

Time frame:: Up to 24 weeks

Results for this outcome have not been posted.

SecondaryClinical Global Impression-Severity

Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).

Time frame:: Baseline (before treatment), post-treatment assessment (on average 12 weeks), one month follow up; Baseline scores reported.
Reported as:: Mean · score on a scale

Clinical Global Impression-Severity
score on a scale	Standard SPACE	Bibliotherapy, Low Therapist Contact SPACE
Clinical Global Impression-Severity	2.42 ± 0.89	2.52 ± 0.93

Adverse events

Collected over Participants were assessed up to 16 weeks. Non-responders to bibliotherapy had the option to participate in standard SPACE, and were possibly followed for an additional 8 weeks (for a total of 24 weeks). Adverse event data were collected for child participants only and were collected for the duration of a participant's involvement in the study.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Standard SPACE	0/33 (0%)	0/33 (0%)	0/33 (0%)
Bibliotherapy, Low Therapist Contact SPACE	0/35 (0%)	0/35 (0%)	0/35 (0%)

Baseline characteristics

Baseline Characteristics were not collected for Parents and only reflect the Child.

Age, Categorical
Age, Categorical(Participants)	Standard SPACE	Bibliotherapy, Low Therapist Contact SPACE	Total
<=18 years	33	35	68
Between 18 and 65 years	0	0	0
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	Standard SPACE	Bibliotherapy, Low Therapist Contact SPACE	Total
Mean	10.2 ± 2.6	10.2 ± 2.8	10.2 ± 2.7

Sex: Female, Male
Sex: Female, Male(Participants)	Standard SPACE	Bibliotherapy, Low Therapist Contact SPACE	Total
Female	15	18	33
Male	18	17	35

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Standard SPACE	Bibliotherapy, Low Therapist Contact SPACE	Total
Hispanic or Latino	10	11	21
Not Hispanic or Latino	23	24	47
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Standard SPACE	Bibliotherapy, Low Therapist Contact SPACE	Total
American Indian or Alaska Native	0	0	0
Asian	5	4	9
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	1	1	2
White	21	21	42
More than one race	6	6	12
Unknown or Not Reported	0	3	3

Region of Enrollment
Region of Enrollment(participants)	Standard SPACE	Bibliotherapy, Low Therapist Contact SPACE	Total
United States	33	35	68

Clinical Global Impressions Scale-Severity
Clinical Global Impressions Scale-Severity(units on a scale)	Standard SPACE	Bibliotherapy, Low Therapist Contact SPACE	Total
Mean	3.48 ± .67	3.54 ± .82	3.51 ± .74

Pediatric Anxiety Rating Scale-Revised
Pediatric Anxiety Rating Scale-Revised(units on a scale)	Standard SPACE	Bibliotherapy, Low Therapist Contact SPACE	Total
Mean	17.63 ± 2.67	16.51 ± 4.14	17.06 ± 3.52

Study locations

1 site

Baylor College of Medicine
Houston, Texas 77030, United States

References and documents

Publications

Storch EA, Guzick AG, Ayton DM, Palo AD, Kook M, Candelari AE, Maye CE, McNeel M, Trent ES, Garcia JL, Onyeka OC, Rast CE, Shimshoni Y, Lebowitz ER, Goodman WK. Randomized trial comparing standard versus light intensity parent training for anxious youth. Behav Res Ther. 2024 Feb;173:104451. doi: 10.1016/j.brat.2023.104451. Epub 2023 Dec 17. PubMed 38154287 ↗

Study documents

Protocol, analysis plan and consent form ↗ · Dec 20, 2023

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2021 to primary completion in Dec 2023, 29 months.

Results were first posted in Jan 2025, 1 year after primary completion.

Of 22 interventional studies with no phase under Anxiety, Separation, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 45. This study's 29 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered: May 25, 2021
First posted: Jun 10, 2021
StartActual: Jul 1, 2021
Primary completionActual: Dec 22, 2023
CompletionActual: Dec 22, 2023
Results first posted: Jan 15, 2025
Last update: Mar 4, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04922502
Lead sponsor: Baylor College of Medicine
Responsible party: Eric A Storch (Professor, Baylor College of Medicine) — Principal investigator
First posted: Jun 10, 2021
Start date: Jul 1, 2021
Primary completion: Dec 22, 2023
Completion: Dec 22, 2023
Results posted: Jan 15, 2025
Last update: Mar 4, 2025

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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